A Research Study to Assess if CC-930 is Safe in Treating Subjects With Discoid Lupus Erythematosus
Recruiting at18 trial locations
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Celgene
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The purpose of the study is to assess if CC-930 is safe and tolerable in treating subjects with Discoid Lupus Erythematosus. Pharmacokinetic and pharmacodynamics will also be evaluated.
Research Team
WS
William Smith, MD
Principal Investigator
Celgene
Eligibility Criteria
Inclusion Criteria
Male or female with clinical diagnosis of Discoid Lupus Erythematosus (DLE) aged 18 to 64 years
Good health as assessed by Investigator DLE for at least 16 weeks prior to screening and consistent histological findings.
Considered a candidate for systemic therapy. May be naïve to systemic therapy or experiencing incomplete or refractory disease on systemic therapy.
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Treatment Details
Interventions
- CC-930 (Unknown)
- Placebo (Unknown)
Participant Groups
4Treatment groups
Experimental Treatment
Group I: Cohort 4Experimental Treatment2 Interventions
100 mg twice daily for 6 weeks (8 active/2 control)
Group II: Cohort 3Experimental Treatment2 Interventions
100 mg daily for 6 weeks (8 active/2 control)
Group III: Cohort 2Experimental Treatment2 Interventions
50 mg once daily for 4 weeks (8 active/2 control)
Group IV: Cohort 1Experimental Treatment2 Interventions
25 mg daily for 4 weeks (8 active/2 control)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Celgene
Lead Sponsor
Trials
649
Recruited
130,000+
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Jay Backstrom
Celgene
Chief Medical Officer since 2016
MD
Mark Alles
Celgene
Chief Executive Officer since 2016
Bachelor's degree from Lock Haven University of Pennsylvania